Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults

Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last
decade, current first-line ART regimens are imperfect. The ideal combination, unlike some
current first-line options, would have uncompromised efficacy in the presence of transmitted
drug-resistant variants. The primary purpose of this study is to estimate the cumulative
proportion of ART-naive participants experiencing virologic failure at or prior to week 24
after initiating raltegravir (RAL) plus darunavir/ritonavir (DRV/RTV).

The study will last 52 weeks. All participants will follow the same treatment schedule and
take RAL plus DRV/RTV orally daily for the duration of the trial.

After entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and
52. Medical/medication history, blood and urine collection, and liver function tests will
occur at screening. A targeted physical exam and concomitant medications history will occur
at all study visits. Blood and urine collection and liver function tests will occur at most
study visits. For females, a pregnancy test will occur at screening and study entry.

RAL and DRV were provided by the study. RTV was not provided by the study.

Inclusion Criteria:

- HIV-1-infected

- Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry

- HIV genotype (for reverse transcriptase and protease) performed at any time prior to
study entry. More information on this criterion can be found in the protocol.

- ARV drug-naive. More information on this criterion can be found in the protocol.

- Negative result from a hepatitis B surface antigen test performed within 90 days prior
to study entry

- Agree to use one form of medically-accepted contraceptive throughout the study and for
60 days after stopping study treatment. More information on this criterion can be
found in the protocol.

Exclusion Criteria:

- Serious illness requiring systemic treatment and/or hospitalization for at least 7
days prior to study. More information on this criterion can be found in the protocol.

- Screening HIV genotype obtained any time prior to study entry with more than one DRV
resistance-associated mutation [RAM] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P,
I84V, and L89V) or L76V alone

- Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S

- Severe renal insufficiency requiring hemodialysis or peritoneal dialysis

- Treatment with immunomodulators within 30 days prior to study entry. More information
on this criterion can be found in the protocol.

- Current medications that are prohibited with any study medications. More information
on this criterion can be found in the protocol.

- Known allergy/sensitivity to study drugs or their formulations. A history of sulfa
allergy is not an exclusion.

- Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with the study.

- Certain abnormal laboratory results. More information on this criterion can be found
in the protocol.

- Pregnant or breastfeeding